Primary objective: to investigate the intra- and interfraction motility of the CTV (the primary tumor as well as any affected celiac lymph nodes) in radiotherapy for esophageal cancer, and to determine adequate CTV-ITV margins.Secondary objective:…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The intra- and inter fraction motility of the CTV (both random and systematic
errors) will be used to design a margin recipe: based on the differences a
formula will be given for the expansion from CTV to ITV, which will ensure a
change for coverage of the target volume of at least 95% on every treatment
day.
Secondary outcome
Based on the differences in the motility on the two 4DCT scans, it will be
investigated whether one 4DCT scan is sufficient for determination of the
intra-fraction motility.
Background summary
Radiotherapy plays an important role in the treatment of esophageal cancer. The
esophagus is a very motile organ due to respiration, heartbeat, peristalsis,
dilatation and gastric filling. This motility needs to be incorporated in the
radiation plan, so that the clinical target volume (CTV) is adequately covered
without underdosage. To accomplish this, the CTV needs to be expanded with
adequate margins to an internal target volume (ITV), around which the planning
target volume (PTV) is defined. Unfortunately, there is only limited data
available on the magnitude of the esophageal motility.
Study objective
Primary objective: to investigate the intra- and interfraction motility of the
CTV (the primary tumor as well as any affected celiac lymph nodes) in
radiotherapy for esophageal cancer, and to determine adequate CTV-ITV margins.
Secondary objective: to investigate whether one 4DCT scan is sufficient for
determination of intra-fraction motility.
Study design
This is an observational study. Of all participating patients who will be
treated with long course radiotherapy (*10 fractions, with or without
chemotherapy) four additional CT scans and two additional 4DCT scans will be
acquired in the first two treatment weeks. The motility will be evaluated by
delineation of the CTV onto all CT scans.
Study burden and risks
Participants will undergo 4 additional CT scans en two 4DCT scans immediately
prior to or after a treatment fraction in the first two weeks of their
treatment. The 4DCT will be made at the same session as the planning CT and one
of the additional CT scans and only acquire a few minutes more. The total
estimated additional time investment of the patient is 60 minutes (15 minutes
per additional CT).
The estimated total extra radiation as a result of the additional scans is
0,18-0,24 Gy, which is 0,3-0,8% of the total treatment dose. The risks of this
additional dose is negligible.
Albinusdreef 2
Leiden 2333 Za
NL
Albinusdreef 2
Leiden 2333 Za
NL
Listed location countries
Age
Inclusion criteria
Esophageal cancer
cT1-3, any N
WHO<=< 2
Exclusion criteria
Previous thoracic surgery
Previous thoracic radiotherapy
cT4
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41642.058.12 |